Regulatory Compliance And Viral Vectors

Regulatory compliance is top of mind for those who use viral vectors, as there is uncertainty around the regulatory challenges. Here, In this segment, Dave Maheu, VP, Head of Process & Analytical Development at Candel Therapeutics and Curran Simpson, Chief Operating Officer at REGENXBIO detail the specific regulatory challenges for advanced therapies as well as how the regulatory requirements differ in early research and development in academia and in industrial vector production. They also discuss how small and merging CGT biotechs can work with the FDA to optimize manufacturing processes to meet the increasing demand for high-quality viral vectors.